[Federal Register Volume 75, Number 127 (Friday, July 2, 2010)]
[Notices]
[Pages 38532-38533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-16139]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2010-M-0068, FDA-2010-M-0078, FDA-2010-M-0063, FDA-
2010-M-0135, FDA-2010-M-0158]
Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved. This
list is intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the Internet and the
agency's Division of Dockets Management.
ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness data to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Please cite the appropriate docket number as listed in table
1 of this document when submitting a written request. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
summaries of safety and effectiveness.
FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 30, 1998 (63 FR 4571), FDA
published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to
discontinue individual publication of PMA approvals and denials in the
Federal Register. Instead, the agency now posts this information on the
Internet on FDA's home page at http://www.fda.gov. FDA believes that
this procedure expedites public notification of these actions because
announcements can be placed on the Internet more quickly than they can
be published in the Federal Register, and FDA believes that the
Internet is accessible to more people than the Federal Register.
In accordance with section 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the act. The 30-day
period for requesting reconsideration of an FDA action under Sec.
10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA
begins on the day the notice is placed on the Internet. Section
10.33(b) provides that
[[Page 38533]]
FDA may, for good cause, extend this 30-day period. Reconsideration of
a denial or withdrawal of approval of a PMA may be sought only by the
applicant; in these cases, the 30-day period will begin when the
applicant is notified by FDA in writing of its decision.
The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from January 1, 2010, through March 31,
2010. There were no denial actions during this period. The list
provides the manufacturer's name, the product's generic name or the
trade name, and the approval date.
Table 1--List of Safety and Effectiveness Summaries for Approved PMAs
Made Available From January 1, 2010, through March 31, 2010
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PMA No. Docket Approval
No. Applicant Trade Name Date
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P010047 Neomend, Inc. PROGEL PLEURAL AIR LEAK January
FDA-2010-M-0068 SEALANT 14, 2010
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P060040/S005 Thoratec Corp. THORATEC HEARTMATE II January
FDA-2010-M-0078 LEFT VENTRICULAR ASSIST 20, 2010
SYSTEM (LVAS)
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H080002 Medtronic, MEDTRONIC MELODY January
FDA-2010-M-0063 Inc. TRANSCATHETER PULMONARY 25, 2010
VALVE (MODEL PB10) AND
MEDTRONIC ENSEMBLE
TRANSCATHETER VALVE
DELIVERY SYSTEM (NU10)
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P090003 Boston EXPRESS LD LLIAC March 5,
FDA-2010-M-0135 Scientific PREMOUNTED STENT SYSTEM 2010
Corp.
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P090006 Medtronic COMPLETE SE VASCULAR March 17,
FDA-2010-M-0158 Vascular STENT SYSTEM 2010
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II. Electronic Access
Persons with access to the Internet may obtain the documents at
http://www.fda.gov/cdrh/pmapage.html.
Dated: June 28, 2010.
Nancy Stade,
Acting Associate Director for Regulations and Policy, Center for
Devices and Radiological Health.
[FR Doc. 2010-16139 Filed 7-1-10; 8:45 am]
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